Speed up the access to and uptake of an Mpox vaccine

The objective of this call for tender is to strengthen the scientific evidence on the immune response provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, with particular emphasis on the need and optimal timing of booster doses. Therefore, the purpose of this call for tenders is to purchase …

CPV: 73000000 Výskum a vývoj a súvisiace poradenské služby, 73300000 Projektovanie a realizácia výskumu a vývoja
Miesto vykonania:
Speed up the access to and uptake of an Mpox vaccine
Udeľujúci orgán:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Číslo udelenia:
HADEA/2025/OP/0013

1. Buyer

1.1 Buyer

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Speed up the access to and uptake of an Mpox vaccine
Description : The objective of this call for tender is to strengthen the scientific evidence on the immune response provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, with particular emphasis on the need and optimal timing of booster doses. Therefore, the purpose of this call for tenders is to purchase clinical services for clinical research and/or other equivalent scientific activities to evaluate and compare the immunogenicity of a booster dose of MVA-BN vaccine considering different routes of administration, namely intradermal and subcutaneous injection, and the appropriate timing of the booster dose. The activities under this call are expected to include a Phase II and/or Phase III clinical trial(s). The results of the clinical trial(s) should be able to contribute to the development and refinement of vaccination strategies to be adopted by public health authorities, as well as, provide further evidence for the European Commission and EU Member States to consider when developing relevant policies, e.g. on stockpiling initiatives, and/or the feasibility of dose-sparing strategies for Mpox vaccination during shortages
Procedure identifier : 6f497612-8ee1-4d01-83c4-5341cb1c9aeb
Previous notice : 163055-2025
Internal identifier : HADEA/2025/OP/0013
Type of procedure : Open

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services

2.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

2.1.3 Value

Estimated value excluding VAT : 4 900 000 Euro

2.1.4 General information

Legal basis :
Regulation (EU, Euratom) 2024/2509

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Speed up the access to and uptake of an Mpox vaccine
Description : The objective of this call for tender is to strengthen the scientific evidence on the immune response provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, with particular emphasis on the need and optimal timing of booster doses. Therefore, the purpose of this call for tenders is to purchase clinical services for clinical research and/or other equivalent scientific activities to evaluate and compare the immunogenicity of a booster dose of MVA-BN vaccine considering different routes of administration, namely intradermal and subcutaneous injection, and the appropriate timing of the booster dose. The activities under this call are expected to include a Phase II and/or Phase III clinical trial(s). The results of the clinical trial(s) should be able to contribute to the development and refinement of vaccination strategies to be adopted by public health authorities, as well as, provide further evidence for the European Commission and EU Member States to consider when developing relevant policies, e.g. on stockpiling initiatives, and/or the feasibility of dose-sparing strategies for Mpox vaccination during shortages
Internal identifier : HADEA/2025/OP/0013

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73300000 Design and execution of research and development

5.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

5.1.3 Estimated duration

Duration : 36 Month

5.1.5 Value

Estimated value excluding VAT : 4 900 000 Euro

5.1.6 General information

Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 109791-2025

5.1.10 Award criteria

Criterion :
Type : Quality
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 80
Criterion :
Type : Price
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 20

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union
Organisation providing more information on the review procedures : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Organisation signing the contract : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

6. Results

Value of all contracts awarded in this notice : 4 900 000 Euro

6.1 Result lot ldentifier : LOT-0001

At least one winner was chosen.

6.1.2 Information about winners

Winner :
Official name : FOLKHALSOMYNDIGHETEN
Tender :
Tender identifier : FOLKHALSOMYNDIGHETEN
Identifier of lot or group of lots : LOT-0001
Value of the tender : 4 900 000 Euro
Subcontracting : No
Contract information :
Identifier of the contract : HADEA/2025/OP/0013
Date on which the winner was chosen : 16/06/2025
Date of the conclusion of the contract : 10/07/2025
Information about European Union funds
Name of EU-financed project or programme : EU4Health Programme (2021/2027)
Organisation signing the contract : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders submitted electronically
Number of tenders or requests to participate received : 1

8. Organisations

8.1 ORG-0001

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Registration number : HADEA
Department : HADEA - Directorate of HaDEA,HADEA.A - Health and Food,HADEA.A.2 - EU4Health/SMP Food
Postal address : COV2, Place Charles Rogier 16
Town : Brussels
Postcode : B-1210
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Internet address : https://hadea.ec.europa.eu
Roles of this organisation :
Buyer
Organisation providing more information on the review procedures
Organisation signing the contract

8.1 ORG-0002

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender

8.1 ORG-0004

Official name : FOLKHALSOMYNDIGHETEN
Size of the economic operator : Large
Registration number : SE202100654501
Postal address : NOBELS VAG 18
Town : SOLNA
Postcode : 171 82
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( SEZZZ )
Country : Sweden
Telephone : +46102052000
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

Notice information

Notice identifier/version : 8f2dde28-183d-4682-8601-5d9226851515 - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 25/07/2025 11:04 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00490627-2025
OJ S issue number : 142/2025
Publication date : 28/07/2025